Experts question automatic osteoporosis drug holidays

Editorial finds that the benefits of continuing therapy in high risk patients greatly exceeds the risk of rare side effects; calls on doctors to individualize treatment decisions based on a patient's fracture risk

Nyon, Switzerland - January 4, 2016 A new editorial published by an International Osteoporosis Foundation (IOF) Working Group urges physicians to individualize treatment decisions based on their patients' fracture risk, rather than automatically interrupting or stopping bisphosphonate therapy after five or three years.

The concept of a bisphosphonate 'holiday' arose following concerns about osteonecrosis of the jaw (ONJ) and atypical femoral fracture (AFF), rare events which have recently been linked to long-term use of bisphosphonates.

Bisphosphonates are a family of drugs used to treat osteoporosis. They bind to the surface of bone and slow down bone-eroding cells (osteoclasts), The therapies effectively reduce the risk of hip, vertebral and other fractures in patients with osteoporosis. Because bisphosphonates reside in bone even after the patient stops taking the medication, they have a persistent, although gradually waning, effect on bone.

The editorial raises the following issues:

Some physicians are automatically stopping bisphosphonates in patients without consideration of the patient's high risk of fracture.

Some physicians mistakenly extend the holiday concept to other antiresorptive drugs, where bone density gains are quickly lost when the drugs are discontinued.

The concept of a need for a drug holiday fuels concerns in patients about rare side effects and makes them unnecessarily fearful of anti-osteoporosis drugs.

Adherence to osteoporosis drug treatment is uniformly low and the above-mentioned concerns are leading to even lower uptake of medication - with greater numbers of high-risk patients left unprotected against fractures.

"There is much clinical confusion about best practice. We have little global consensus on how to identify which patients should have a drug holiday, and how to manage and monitor these patients. More research is needed so that we can provide physicians with clear recommendations," said lead author Professor Stuart Silverman, Cedars-Sinai Medical Center and Professor of Medicine, University of California, Los Angeles (UCLA).

"In the meantime we want to remind physicians and patients alike that while the incidence of AFF and ONJ are very rare, hip and spinal fractures in high risk patients are, in contrast, far more common and a major cause of disability, loss of quality of life and early death. The benefits of bisphosphonate therapy with regard to reduced fracture incidence in moderate and high risk women clearly outweigh the risk of rare adverse events."

The authors suggest that clinicians need to rethink the assumption that a patient who has taken an oral bisphosphonate for five years or an intravenous therapy for three years should automatically start a drug holiday. Instead the clinician should individualize the decision for each patient based on their fracture risk.

The International Osteoporosis Foundation (IOF) is a not-for-profit, nongovernmental organization dedicated to the worldwide fight against osteoporosis and related musculoskeletal diseases. IOF's members - scientific researchers, patient, medical and research societies and industry representatives from around the world - share a common vision of a world without osteoporotic fractures. IOF, with headquarters in Switzerland, currently includes 232 member societies in 98 countries, regions and territories. Among its numerous programmes and activities, IOF mobilizes the global osteoporosis movement on World Osteoporosis Day, marked on October 20 every year. http://www.iofbonehealth.org; http://www.facebook.com/iofbonehealth; http://twitter.com/iofbonehealth

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